Dataset Information

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

ABSTRACT: BACKGROUND:Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage or sepsis. This study evaluated the usability and acceptability of the CRADLE VSA device. METHODS:Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria and tertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups with healthcare workers using the device (n =?205) and pregnant women and their family members (n =?41). Interviews and focus groups were conducted in the local language and audio-recorded, transcribed and translated into English for analysis. Thematic analysis was undertaken using an a priori thematic framework, as well as an inductive approach. RESULTS:Most healthcare workers perceived the CRADLE device to be easy to use and accurate. The traffic lights early warning system was unanimously reported positively, giving healthcare workers confidence with decision-making and a sense of professionalism. However, a minority in South Africa described manual inflation as tiring, particularly when measuring vital signs in obese and hypertensive women (n?=?4) and a few South African healthcare workers distrusted the device's accuracy (n =?7). Unanimously, pregnant women liked the CRADLE device. The traffic light early warning system gave women and their families a better understanding of the importance of vital signs in pregnancy and during the postpartum period. CONCLUSION:The CRADLE device was well accepted by healthcare workers from a range of countries and levels of facility, including those with no previous vital signs measurement experience. The device motivated women to attend primary care and encouraged them to accept treatment and referral.

SUBMITTER: Nathan HL

PROVIDER: S-EPMC5756409 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

Nathan Hannah L HL Boene Helena H Munguambe Khatia K Sevene Esperança E Akeju David D Adetoro Olalekan O OO Charanthimath Umesh U Bellad Mrutyunjaya B MB de Greeff Annemarie A Anthony John J Hall David R DR Steyn Wilhelm W Vidler Marianne M von Dadelszen Peter P Chappell Lucy C LC Sandall Jane J Shennan Andrew H AH

Reproductive health 20180105 1

<h4>Background</h4>Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare worke ...[more]

PMID: 29304812

Similar Datasets

Project description:BackgroundThe CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined.MethodsThe fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4-10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection.ResultsThe package was implemented with high fidelity (85% of HCP trained, n?=?204). The questionnaires indicated a good understanding of device use with 75% of participants scoring >?75% (n?=?97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation.ConclusionsThis feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial.Trial registrationISRCTN41244132 ; Registered 24/11/2015.

Project description:BackgroundIn 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy).MethodsWe did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132.FindingsBetween April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86-0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73-2·06; p=0·45).InterpretationThere was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials.FundingNewton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.

Project description:ObjectiveTo assess the impact of mobile virtual reality (VR) simulations using electronic Helping Babies Breathe (eHBB) or video for the maintenance of neonatal resuscitation skills in healthcare workers in resource-scarce settings.DesignRandomised controlled trial with 6-month follow-up (2018-2020).SettingSecondary and tertiary healthcare facilities.Participants274 nurses and midwives assigned to labour and delivery, operating room and newborn care units were recruited from 20 healthcare facilities in Nigeria and Kenya and randomised to one of three groups: VR (eHBB+digital guide), video (video+digital guide) or control (digital guide only) groups before an in-person HBB course.InterventionseHBB VR simulation or neonatal resuscitation video.Main outcomesHealthcare worker neonatal resuscitation skills using standardised checklists in a simulated setting at 1 month, 3 months and 6 months.ResultsNeonatal resuscitation skills pass rates were similar among the groups at 6-month follow-up for bag-and-mask ventilation (BMV) skills check (VR 28%, video 25%, control 22%, p=0.71), objective structured clinical examination (OSCE) A (VR 76%, video 76%, control 72%, p=0.78) and OSCE B (VR 62%, video 60%, control 49%, p=0.18). Relative to the immediate postcourse assessments, there was greater retention of BMV skills at 6 months in the VR group (-15% VR, p=0.10; -21% video, p<0.01, -27% control, p=0.001). OSCE B pass rates in the VR group were numerically higher at 3 months (+4%, p=0.64) and 6 months (+3%, p=0.74) and lower in the video (-21% at 3 months, p<0.001; -14% at 6 months, p=0.066) and control groups (-7% at 3 months, p=0.43; -14% at 6 months, p=0.10). On follow-up survey, 95% (n=65) of respondents in the VR group and 98% (n=82) in the video group would use their assigned intervention again.ConclusioneHBB VR training was highly acceptable to healthcare workers in low-income to middle-income countries and may provide additional support for neonatal resuscitation skills retention compared with other digital interventions.

Project description:BackgroundInterventions aimed at reducing maternal mortality are increasingly complex. Understanding how complex interventions are delivered, to whom, and how they work is key in ensuring their rapid scale-up. We delivered a vital signs triage intervention into routine maternity care in eight low- and middle-income countries with the aim of reducing a composite outcome of morbidity and mortality. This was a pragmatic, hybrid effectiveness-implementation stepped-wedge randomised controlled trial. In this study, we present the results of the mixed-methods process evaluation. The aim was to describe implementation and local context and integrate results to determine whether differences in the effect of the intervention across sites could be explained.MethodsThe duration and content of implementation, uptake of the intervention and its impact on clinical management were recorded. These were integrated with interviews (n = 36) and focus groups (n = 19) at 3 months and 6-9 months after implementation. In order to determine the effect of implementation on effectiveness, measures were ranked and averaged across implementation domains to create a composite implementation strength score and then correlated with the primary outcome.ResultsOverall, 61.1% (n = 2747) of health care providers were trained in the intervention (range 16.5% to 89.2%) over a mean of 10.8 days. Uptake and acceptability of the intervention was good. All clusters demonstrated improved availability of vital signs equipment. There was an increase in the proportion of women having their blood pressure measured in pregnancy following the intervention (79.2% vs. 97.6%; OR 1.30 (1.29-1.31)) and no significant change in referral rates (3.7% vs. 4.4% OR 0.89; (0.39-2.05)). Availability of resources and acceptable, effective referral systems influenced health care provider interaction with the intervention. There was no correlation between process measures within or between domains, or between the composite score and the primary outcome.ConclusionsThis process evaluation has successfully described the quantity and quality of implementation. Variation in implementation and context did not explain differences in the effectiveness of the intervention on maternal mortality and morbidity. We suggest future trials should prioritise in-depth evaluation of local context and clinical pathways.Trial registrationTrial registration: ISRCTN41244132 . Registered on 2 Feb 2016.

Project description:BackgroundObstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations.MethodsThe CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken.DiscussionAll aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers.Trial registrationISCRTN41244132. Registered on 2 February 2016. Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1.

Project description:BackgroundAgeing into adulthood is challenging at baseline, and doing so with a chronic disease can add increased stress and vulnerability. Worldwide, a substantial care gap exists as children transition from care in a paediatric to adult setting. There is no current consensus on safe and equitable healthcare transition (HCT) for patients with chronic disease in resource-denied settings. Much of the existing literature is specific to HIV care. The objective of this narrative review was to summarise current literature related to adolescent HCT not associated with HIV, in low-income and middle-income countries (LMICs) and other resource-denied settings, in order to inform equitable health policy strategies.MethodsA literature search was performed using defined search terms in PubMed and Cumulative Index to Nursing and Allied Health Literature databases to identify all peer-reviewed studies published until January 2020, pertaining to paediatric to adult HCT for adolescents and young adults with chronic disease in resource-denied settings. Following deduplication, 1111 studies were screened and reviewed by two independent reviewers, of which 10 studies met the inclusion criteria. Resulting studies were included in thematic analysis and narrative synthesis.ResultsTwelve subthemes emerged, leading to recommendations which support equitable and age-appropriate adolescent care. Recommendations include (1) improvement of community health education and resilience tools for puberty, reproductive health and mental health comorbidities; (2) strengthening of health systems to create individualised adolescent-responsive policy; (3) incorporation of social and financial resources in the healthcare setting; and (4) formalisation of institution-wide procedures to address community-identified barriers to successful transition.ConclusionLimitations of existing evidence relate to the paucity of formal policy for paediatric to adult transition in LMICs for patients with childhood-onset conditions, in the absence of a diagnosis of HIV. With a rise in successful treatments for paediatric-onset chronic disease, adolescent health and transition programmes are needed to guide effective health policy and risk reduction for adolescents in resource-denied settings.

Dataset Information

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

Publications

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets